Relative Bioavailability of Dextromethorphan Syrup in Comparison to Dextromethorphan Soft Pastilles in Healthy Male and Female Subjects

NCT02191709 | Completed Phase 1

• 1 other identifier: 1134.2
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the relative bioavailability of orally administered dextromethorphan syrup in comparison to dextromethorphan (DMP) soft pastilles in healthy male and female subjects who are extensive metabolisers for CYP 2D6

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) - for dextromethorphan and dextrorphan (total and free)

  predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration

• Cmax (maximum measured concentration of the analyte in plasma) - for dextromethorphan and dextrorphan (total and free)

  predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration

• tmax (time from dosing to the maximum measured concentration of the analyte in plasma) - for dextromethorphan and dextrorphan (total and free)

  predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration

Secondary Outcomes (16)

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) - all analytes

  predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration

• AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2) - all analytes

  predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration

• %AUCtz-∞ (percentage of the AUC0-∞ that is obtained by extrapolation) - all analytes

  predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration

• λz (terminal rate constant in plasma) - all analytes

  predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration

• t1/2 (terminal half-life of the analyte in plasma) - all analytes

  predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration

Study Arms (2)

Dextromethorphan syrup

EXPERIMENTAL

Bisoltussin® Syrup

Drug: Dextromethorphan syrup

Dextromethorphan soft pastilles

ACTIVE COMPARATOR

Silomat® DMP soft pastilles

Drug: Dextromethorphan soft pastilles

Interventions

Dextromethorphan syrup DRUG

Dextromethorphan syrup

Dextromethorphan soft pastilles DRUG

Dextromethorphan soft pastilles

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
• Age ≥18 and Age ≤55 years
• BMI ≥18.5 and BMI ≤30 kg/m2 (Body Mass Index)
• Extensive metabolisers for CYP 2D6
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

You may not qualify if:

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Use of drugs which might reasonably influence the results of the trial or which prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within one month prior to administration or during the trial
• Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 60 g/day)
• Drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 16, 2014
• Study Start: January 1, 2009
• Primary Completion: February 1, 2009
• Last Updated: July 16, 2014

Record last verified: 2014-07